510(k) · Cleared
Recalled · Class II · 2022HydroMID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Vascular, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 8, 2021 as substantially equivalent to K150407 (Navilyst Medical, Inc., 2015) after a 122-day review. Its family tree reaches back 9 generations to 1993. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 8, 2021
- Review
- 122 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K932323 (1993). 24 ancestors in all, the oldest K801941 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 5 generations between
- 3 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 2 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 1 generation backK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- This deviceK203069 HydroMIDAccess Vascular, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK220772 HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK243458 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic…Access Vascular, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK244059 HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)…Access Vascular, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 8 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 7 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 6 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 5 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 4 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 3 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 2 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 1 generation backK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- This deviceK203069 HydroMIDAccess Vascular, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022 · cites it directly2descendants
- K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc. · 2025 · 2 generations on0descendants
- K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…Access Vascular, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −8 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −7 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −6 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −5 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −4 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −3 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| −2 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| −1 | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
| 0 (this device) | K203069 | HydroMID | Access Vascular, Inc. | 2021 | — |
| +1 | K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022 | — |
| +2 | K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit… | Access Vascular, Inc. | 2025 | — |
| +2 | K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F… | Access Vascular, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150407 | BioFlo Midline CatheterSummary page 4…Primary Predicate Device Trade Name: BioFlo Midline Catheter Manufacturer: AngioDynamics Inc. (Formerly Navilyst Medical, Inc.) 510(k) Reference: K150407 Common Name: Intravascular Catheter Regulation Number: 21 CFR§880.5200 Regulation Name: Catheter, Intravascular, Th… | 2015 |
| † | K193015 | HydroPICC (PICC-142) | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220772 | HydroMID 4F Single Lumen Midline Catheter | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2022 | Class II | Z-1156-2023 | Under Investigation by firm | Label with the incorrect component listed on the inner kit Tyvek header bag |
| Dec 22, 2022 | Class II | Z-1155-2023 | Under Investigation by firm | Product Mislabeled on the outer bag and inner kit Tyvek header bag |
| Dec 16, 2022 | Class II | Z-1129-2023 | Incorrect or no expiration date | Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K220772 (Access Vascular, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K150407.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L.
HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203069: HydroMID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203069
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026